Quality Assurance Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About Innovative Medicine

Ourexpertisein Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for a Quality Assurance Specialist position to be located in Sassenheim Netherlands.

The contract will initially commence as a 12month fixedterm agreement with the possibility of extension subject to satisfactory performance and business needs.

QA-AT supports the clinical and commercial manufacturing of Lentivirus an important component for Johnson and Johnsons CAR-T therapy.

The QA Specialist acts as a quality expert and ensures quality oversight of our AT products and processes. Plays a crucial role in ensuring that our manufacturing operations meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. The Specialist QA works in close collaboration with other local or global departments (Operations Warehouse QC GET MSAT and other site Quality teams).

Essential Job duties and responsibilities as a Quality Assurance Specialist you will:

• Review and approve routine GMP documentation for all components of the Quality system.

• Reviews and approves validation protocols and reports CSV documentation change controls validation assessments URS and applicable lifecycle documentation.

• Reviews and approves release documentation for (raw) materials or Drug Substance including QA review of electronic batch records and related documentation (e.g. QC test results QC trending data SAP tags and related change controls).

• Reviews and approves Maintenance notifications and work orders (NI-NS) and SAP-PM Master Data Changes (N2 N5 and N6) as well as the approval of Maintenance and Calibration related documents (as needed).

• Executes Quality Aseptic Processing Oversight activities verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.

• Track and monitor progress of changes to anticipate flag and prevent any delays in change implementation.

• Performs the Quality review of Periodic Review reports.

• Quality overview of the validated state of the utilities equipment and processes.

• Promotes improvement initiatives to set up standardize and lean out QA processes within the team.

• Provides Site support for local or global projects as an SME or QA core team member.

• Engages in internal audits and inspections as an SME or in support functions.

• Escalates serious quality compliance and /or GMP incidents to management.

• On a rotation basis is available for quality oversight is needed during manufacturing (e.g. QAPOP)

Experience and Skills

• Degree in science related subject and /or business-related area with 2-4 years of experience in a GMP regulated environment (manufacturing QA and/or QC) in a pharmaceutical company. QA experience is required.

• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.

• Knowledge of current Quality Management principles GMP and Quality Systems Pharma regulations.

• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.

• Problem solving analytical thinking and decision making capabilities.

• Demonstrated proficiency in English both in word and in writing. Dutch is a pre but not mandatory.

Salary:

The anticipated base pay range for this position is 44700.00 to 70840.00

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.

• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process!

#RPOEMEA #SCQuality

Required Skills:

Preferred Skills: